Biden’s recent support of the waiver of the Covid-19 vaccine patents rights is a step in the right direction of a long road towards increasing vaccine availability. In this article we explore the legality and practicality of the patent waiver and its effect on vaccine production.
What is a patent?
A patent is a title that gives its owner the legal right to exclude others from using an invention for a limited period of years in exchange for publishing an enabling public disclosure of the invention. Pharmaceutical companies file for patents so that they can have the exclusive right to sell and manufacture their patentable drugs for a period.
A waiver is a demonstration, usually in written form, of a party’s intent to relinquish a legal right or claim.
Tripping over TRIPS
The Agreement on Trade-Related Aspects of Intellectual Property Rights is an international legal agreement between all countries of the World Trade Organization. This agreement governs the use of patents among the member countries. It permits the countries to license the patent only in particular circumstances.
Back in October 2020, India and South Africa petitioned the WTO, seeking a broad and temporary waiver of the provisions of TRIPS for the production and export of vaccines and other critical medical goods needed to combat the Covid-19 virus.
Who owns what?
Covaxin is developed by Bharat Biotech International Ltd in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Covishield has been developed by the Oxford-AstraZeneca and is being manufactured by the Serum Institute of India (SII).
Traditional vaccines, like India’s Covaxin uses a deactivated covid-19 virus to give you immunity against the disease. This technology has helped us defeat Polio, measles and other diseases.
The current covid crisis has produced breakthroughs in the way we produce vaccines. The Covisheld vaccine and other vaccines use a mRNA — or messenger RNA is new technology which mimics the part of the virus that attacks our cells and teaches our Immunity response to fight against it.
The Covisheld and few other vaccines are made of a new technology for which there is no information available in the public space. This means that even if the Patents are waived, nobody possesses the know-how to manufacture these vaccines.
In early 2020, Bangladesh was able to manufacture significant quantities of Remdesivir without the approval (exempt under article 31 of TRIPS) of the company that owns the Patent (Gilead Science) as the know-how and information about Remsedevir was available and the drug was in the market for many years.
However, nobody will be able to manufacture the new RNA vaccines as the know-how and the manufacturing capabilities are not present with them. This means that even if there are patent waivers, the know-how and the actual trade secrets may not be fully revealed by these patents.
What are compulsory licenses and how can they be used?
Compulsory licenses are authorizations given to a third-party by the Controller General of Patents to make, use or sell a particular product or use a particular process which has been patented, without the need of the permission of the patent owner.
Section 92 of the Indian Patents Act,1970 empowers the Central government, to its satisfaction, to use these powers in case of a national emergency, circumstances of extreme urgency or in case of public non-commercial use.
The Supreme Court on 30th April 2021, while dealing with the suo moto petition regarding the management of COVID-19 in India asked why compulsory licensing cannot be invoked under Section 92 of the Patent Act for the manufacture of vaccines.
— Live Law (@LiveLawIndia) April 30, 2021
Livelaw reports that Natco Pharma has filed an application under Section 92(1) read with 92(3) of the Patents Act seeking compulsory license to produce ‘Baricitinib’ (A drug used for covid treatment) at an affordable rate.
Countries around the world are using the compulsory licence to increase availability of life saving drugs. Israel issued a compulsory licence to import generic versions of Ritonavir, a drug that could be a treatment for Covid-19. Canada has amended its Patent Act to quickly issue compulsory licenses by allowing the negotiation of remuneration at a later stage.
The India government is licensing the Covaxin to private and government institutions to increase its availability.
The waiver of patent and TRIPS provisions needs to be looked at as a part of a holistic plan to increase production of vaccines across the world. The problem of vaccine and drug availability needs to be tackled with a view on the larger picture of manufacturing capabilities, know-how and raw material availability.
The U.S. expects negotiations will take a while, White House spokeswoman Karine Jean-Pierre told reporters on Air Force One on Thursday.
“It’s not going to happen tomorrow or the next day — it will take a few months before this happens, and we will continue to have the conversation and also just continue the negotiation,” she said.
Meanwhile, we as citizens must do everything in our power to stop the spread of covid by following the rules and regulations and taking adequate precautions.
Written By: Aditya S Reference : US backs IP rights waiver for Covid vaccines, EU says ready to discuss